RING SIM SR 800SR38 SEMI
ATS SIMULUS® - 800SR38
Device Description
A circular band intended to be implanted in the heart during open heart surgery to support a mitral or tricuspid valve annulus for the reconstruction and/or remodelling of insufficient and/or stenotic mitral or tricuspid valves. It is typically mounted on a disposable holder assembly or preloaded in a disposable delivery system to enable it to maintain its shape and aid in its implantation with sutures or anchors. The device may be semi-rigid or flexible and may include metallic, polymeric, and/or textile materials; it is available in various sizes.
Environmental Conditions
- Store in cool dry place.
- Store the product carton in a temperate, dry place to protect the product and minimize contamination potential.
Device Sizes
- Lumen/Inner Diameter: 38.0 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: KRH
Device Name: Ring, Annuloplasty
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: Y
Target Area: N/A
Regulation Number: 870.3800
Third Party Flag: N
Medical Specialty: CV
Device IdentifiersDevice Id: 00643169301047
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
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